EP3074084B1

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Info

Publication number: EP3074084B1
Application number: EP14863371.2A
Authority: EP
Inventors: N. Sandor Racz; James SHOEMAKE
Original assignee: Custom Medical Applications Inc
Current assignee: Custom Medical Applications Inc
Priority date: 2013-11-25
Filing date: 2014-11-25
Publication date: 2019-10-30
Anticipated expiration: 2034-11-25
Also published as: CN105813689A; KR20160118220A; USD865165S1; JP6697393B2; CA2931459A1; US10226620B2; KR102407167B1; JP2016537179A; AU2014352645A1; EP3074084A1; EP3074084A4; US20170165478A1; AU2014352645B2; CN105813689B; WO2015077796A1; ES2765303T3; CA2931459C

Description

TECHNICAL FIELD

The disclosure relates generally to the field of medical devices and related methods. In particular, the disclosure relates to anchor elements and anchor element assemblies that may be utilized to retain at least a portion of a medical device (e.g., a medical therapy delivery device) within a subject and related methods.

BACKGROUND

Implantable medical devices (e.g., medical therapy delivery devices), such as catheters and leads, may be employed for a variety of therapeutic and diagnostic purposes. Controlled placement and retention of such therapy delivery elements within a subject is highly desirable as precise placement and retention may result in improved therapeutic efficacy or reduced side effects. However, the location of the delivery element may change in time. For example, as the subject moves, the location of the implanted delivery element may move or shift within the subject.
Anchors may be placed about the therapy delivery element and sutured to subcutaneous tissue of the subject in order to secure the position of a delivery region of the therapy delivery element (e.g., an infusion section or electrode of the delivery element) relative to a target location of the subject.
WO 2013/070490 shows an anchoring tool for an implantable medical device.US 2008/0183257,US 4 419 819 andEP 0 779 080 show examples of known lead anchor elements.

DISCLOSURE

The present invention is defined by the appended claims. Aspects, embodiments or examples of the present disclosure which do not fall within the scope of the appended claims do not form part of the present invention.
Described are anchor elements, anchor element assemblies, and methods of anchoring at least a portion of a medical device within a subject. Such anchor elements may be positioned and/or deployed within the subject while the at least a portion of the medical device is positioned within (e.g., resident in) a subject. For example, such anchor elements may be positioned and/or deployed within the subject with an anchor deployment device of an anchor element assembly.
In some embodiments, an anchor element assembly comprises at least one anchor element having a longitudinal axis. This anchor element includes at least one lobe section comprising at least one lobe configured to extend transversely or laterally from the longitudinal axis of the at least one anchor element when the anchor element is in a deployed state and a lumen formed within the at least one anchor element configured to receive at least a portion of a medical device in the lumen. The anchor element assembly further comprises an anchor deployment device comprising at least one cannula configured to receive the at least one anchor element on the at least one cannula. The anchor deployment device is configured to secure the anchor deployment device to the at least a portion of the medical device.
In certain embodiments, an anchor element comprising at least one protrusion section comprises at least two circumferentially-spaced protrusions configured to extend transversely or laterally from a longitudinal axis of the anchor element when the anchor element is in a deployed state and a lumen formed within the at least one anchor element configured to receive at least a portion of a medical device in the lumen. The anchor element is configured to be secured over the at least a portion of the medical device while the at least a portion of the medical device is positioned within a subject.
Also disclosed is a method of anchoring a medical device within a subject. The method includes positioning at least a portion of the medical device within the subject, securing the at least a portion of the medical device within a lumen of the at least one anchor element, and deploying at least one protrusion of the at least one anchor element to extend transversely or laterally from a longitudinal axis of the at least one anchor element while the at least a portion of the medical device is positioned within the subject.
Also disclosed are medical device assemblies including such anchor elements and/or anchor element assemblies.
Also disclosed are methods of forming and utilizing anchor elements and anchor element assemblies according to the disclosure.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 depicts a medical device assembly including an anchor element positioned on a medical device in accordance with an embodiment of the disclosure.
FIGS. 2A and 2B depict an anchor element in accordance with an embodiment hereof in an initial state and a deployed state, respectively.
FIGS. 3A and 3B depict an anchor element in accordance with an embodiment hereof in an initial state and a deployed state, respectively.
FIG. 4 depicts an anchor deployment device in accordance with one embodiment.
FIG. 5 depicts a view of the anchor deployment device shown inFIG. 4 beginning to deploy an anchor element.
FIG. 6 depicts a cross-sectional view of a portion of the anchor deployment device shown inFIG. 4 with a medical device received in the anchor deployment device.
FIG. 7 depicts another cross-sectional view of a portion of the anchor deployment device shown inFIG. 4 with the medical device received in the anchor deployment device and an anchor element attached to the anchor deployment device.
FIGS. 8A and 8B depict an anchor element in accordance with an embodiment hereof in an initial state and a deployed state, respectively.
FIGS. 9 and 10 depict a perspective view and a side view, respectively, of an anchor deployment device in accordance with an embodiment of the disclosure.

MODE(S) FOR CARRYING OUT THE INVENTION

Illustrations presented herein are not necessarily meant to be actual views of any particular device, assembly, system, method, or components thereof, but are merely idealized representations, which are employed to describe embodiments of the disclosure. Additionally, elements common between figures may retain the same numerical designation.
FIG. 1 depicts a medical device assembly including ananchor element 100 positioned on a medical device 102 (e.g., a distal portion of the medical device 102). Suchmedical devices 102 may include a diagnostic device, a monitoring device, a therapeutic device, or combinations thereof. For example, themedical device 102 may comprise a medical therapy delivery device, a medical device configured to sense a parameter of the subject, a medical device configured to diagnose a condition, a medical device configured to sample one or more tissues and/or fluids from a subject, or combinations thereof.
Themedical device 102 may be utilized alone to provide a medical service (e.g., diagnostic, monitoring, therapeutic, or combinations thereof) to a subject or may be utilized with one or more medical devices 103 (e.g., a medical device internal or external to the subject that is electrically and/or mechanically coupled to the medical device 102). For example, themedical device 102 and/ordevice 103 may comprise devices such as a pacemaker, defibrillator, monitoring device, infusion device, neurostimulator, gastric stimulator, cochlear device, or any other device that is at least partially subcutaneously implanted in a subject.
In some embodiments, at least a portion of themedical device 102 is positioned proximate the nervous system of a subject (e.g., proximate the spinal cord or canal, brain, and/or peripheral nervous system). Themedical device 102 may be a catheter, a lead, or lead extension. For example, themedical device 102 may be a lead including one or more electrodes on a distal end portion of the lead. Electrical contacts in the lead may be electrically coupled (e.g., physically or wirelessly) to a control module having an electrical signal generator (e.g.,medical device 103 external or internal to the subject) and signals generated by themedical device 103 may be delivered to the subject via the electrodes. In some embodiments, such leads are utilized as implantable stimulation devices, which may be utilized in a variety of treatments and procedures, such as, for example, spinal cord stimulation. For example, implantable stimulation devices may be used to stimulate nerves, such as the spinal cord, muscles, or other tissue. The stimulator electrodes of the leads may be implanted in contact with or near the nerves, muscles, or other tissue to be stimulated. A pulse generator of themedical device 103 generates electrical pulses that are delivered by the electrodes to body tissue. In such embodiments, the lead is anchored at one or more places in the subject to prevent or reduce movement of the lead or stimulator electrodes within the subject (e.g., during short-term or long-term placement of thedevices 102, 103 in the subject) that could damage tissue, move the stimulator electrodes out of the desired position, or interrupt the connection between the stimulator electrodes and themedical device 102, 103.
As shown inFIG. 1, theanchor element 100 is placed over at least a portion of the medical device 102(e.g., a cannula of the medical device 102). For example, at least a portion of themedical device 102 may be positioned within a lumen formed by the tubular body (e.g., cannula) of theanchor element 100. As depicted, theanchor element 100 is shown in a deployed state where one or more protrusions (e.g., one, two, three, four, ormore lobes 104, e.g., circumferentially-spaced lobes) extend outwardly from a portion of the anchor element 100 (e.g., laterally outward from a longitudinal axis or centerline of the anchor element 100). Eachlobe 104 extending laterally from theanchor element 100 may form anopening 107 within thelobe 104.
When attached to themedical device 102, thelobes 104 of theanchor element 100 may anchor themedical device 102 by engaging with one or more portions of the subject. For example, thelobes 104 of theanchor element 100 may engage with a portion of the subject's tissue (e.g., muscle tissue, nervous tissue, connective tissue,etc.) to at least partially retain themedical device 102 in a desired position within the subject. It is also believed that, in some embodiments, regrowth of the tissue of the subject proximate thelobes 104 may intertwine with at least a portion of the lobes 104 (e.g., tissue may extend through the openings 107) further anchoring theanchor element 100 andmedical device 102 within the subject.
Theanchor element 100 may be coupled (e.g., mechanically coupled) to at least a portion of the medical device 102 (e.g., an outer portion or exterior surface of the medical device 102). For example, theanchor element 100 may be secured to themedical device 102 through mechanical interference (e.g., utilizing friction, compression, swaging,etc.) rather than through adhesion or the use of fasteners. Theanchor element 100 may include one or more portions for retaining theanchor element 100 to themedical device 102. For example,engagement portions 106, 108 may be formed on either side of thelobes 104 and may act to secure theanchor element 100 to the medical device 102 (e.g., via a mechanical interference fit). In some embodiments, each of theengagement portions 106, 108 of theanchor element 100 include an inner dimension (e.g., diameter) that is smaller than an outer dimension (e.g., diameter) of themedical device 102. One or more portions of the anchor element 100 (e.g.,engagement portions 106, 108) may be formed from a flexible material (e.g., an elastically deformable material) such as, for example, a polymer (e.g., silicone, polyurethane,etc.). Theflexible engagement portions 106, 108 may be deformed (e.g., elastically deformed) to enlarge a cross-sectional area of a lumen formed within each theengagement portions 106, 108. Theenlarged engagement portions 106, 108 may be positioned over (e.g., around, about) themedical device 102. As theenlarged engagement portions 106, 108 are allowed to contract back to substantially their original size (e.g., cross-sectional area), theengagement portions 106, 108 may engage and couple with themedical device 102.
In some embodiments, one or more ends of theanchor element 100 include ataper 110 or chamfer to assist in insertion of theanchor element 100 into the subject.
FIGS. 2A and 2B depict an anchor element (e.g., anchor element 100) in an initial state (e.g., a retracted or relaxed state) and a deployed state (e.g., a semi-distended state of the inner diameter), respectively. As shown inFIG. 2A, theanchor element 100 includes a protrusion orlobe portion 105 positioned between theengagement portions 106, 108 of theanchor element 100. The body of the anchor element may form alumen 101 therein. The lobes 104 (e.g., two lobes 104) of thelobe portion 105 are formed about the anchor element 100 (e.g., at equal circumferential spacing) byslits 112 in the tubular body of theanchor element 100. In the initial state, thelobe portion 105 of theanchor element 100 is substantially parallel to (e.g., coextensive with) a longitudinal axis L₁₀₀ of theanchor element 100.
Referring also toFIG. 2B, theengagement portions 106, 108 may be moved toward each other to transition theanchor element 100 to the deployed state. Theslits 112 enable thelobes 104 to extend outwardly (e.g., in a direction lateral or transverse (e.g., perpendicular) to the longitudinal axis L₁₀₀ of the anchor element 100) from a portion of the anchor element 100 (e.g., from theengagement portions 106, 108).
FIGS. 3A and 3B depict ananchor element 200 in an initial state (e.g., a retracted state) and a deployed state, respectively. As shown inFIG. 3A, theanchor element 200 may be somewhat similar toanchor element 100 discussed above and the body of theanchor element 200 may form alumen 201 therein. However,anchor element 200 may include more than one lobe portion (e.g., twolobe portions 205, 207) positioned between theengagement portions 206, 208 of theanchor element 200. In other embodiments, theanchor element 200 includes three, four, or more lobe portions. Lobes 204 (e.g., two lobes) of eachlobe portion 205, 207 are formed about the anchor element 200 (e.g., at equal circumferential spacing) byslits 212 in the tubular body of theanchor element 200. In the initial state, thelobe portions 205 of theanchor element 200 are substantially parallel to (e.g., coextensive with) a longitudinal axis L₂₀₀ of theanchor element 200.
In some embodiments, theanchor element 200 includes anadditional engagement portion 209 positioned between thelobe portions 205, 207.
Referring also toFIG. 3B, theengagement portions 206, 208 may be moved toward each other (e.g., toward the additional engagement portion 209) to transition theanchor element 200 to the deployed state. Theslits 212 enable thelobes 204 to extend outwardly (e.g., in a direction lateral or transverse (e.g., perpendicular) to a longitudinal axis L₂₀₀ of the anchor element 200) from a portion of the anchor element 200 (e.g., from theengagement portions 206, 208). As depicted, thelobe portions 205, 207 may be offset from one another (e.g., offset 90 degrees about the longitudinal axis L₂₀₀ of the anchor element 200).
FIG. 4 depicts ananchor deployment device 300 that may be utilized with an anchor element (e.g.,anchor elements 100, 200 discussed above with reference toFIGS. 1 through 3B). As shown inFIG. 4, theanchor deployment device 300 includes a first cannula (e.g., deployment cannula 302) and a second cannula (e.g., anchor cannula 304) received at least partially within thedeployment cannula 302. For example, thedeployment cannula 302 may have an inner dimension (e.g., diameter) that is greater than an outer dimension (e.g., diameter) of theanchor cannula 304 such that theanchor cannula 304 may be received and movable within thedeployment cannula 302. Theanchor deployment device 300 may include ahandle 306 having afirst portion 308 coupled to thedeployment cannula 302 and asecond portion 310 coupled to theanchor cannula 304. Theportions 308, 310 of thehandle 310 may be movable relative to one another(e.g., thesecond portion 310 may slide relative to the first portion 308) in order to move theanchor cannula 304 within thedeployment cannula 302. Eachportion 308, 310 of thehandle 306 may include one ormore grips 314 enabling a user (e.g., medical practitioner) to actuate thehandle 306, thereby sliding thesecond portion 310 relative to thefirst portion 308 along a common axis.
As depicted, theanchor cannula 304 may be sized to receive an anchor element (e.g., anchor element 100) on theanchor cannula 304 atdistal portion 312 of theanchor deployment device 300. The outer dimension (e.g., diameter) of theanchor cannula 304 may be greater than the inner dimension (e.g., diameter) of theanchor element 100. Such a diameter of theanchor cannula 304 may act to enlarge a cross-sectional area of alumen 101 formed within a portion of the anchor element 100 (e.g., at each of theengagement portions 106, 108 (FIG. 1)) to form an initial dimension to an enlarged dimension. For example, theanchor cannula 304 may deform (e.g., elastically deform) theanchor element 100 to a dimension (e.g., diameter) that is greater than a dimension (e.g., diameter) of the medical device 102 (FIG. 1) on which theanchor element 100 is to be placed.
FIG. 5 depicts a view of theanchor deployment device 300 shown inFIG. 4 beginning to deploy an anchor element (e.g.,anchor element 100 in a distended state of the inner diameter). As shown inFIG. 5, at least a portion of a medical device (e.g., medical device 102) may be received within a portion of theanchor deployment device 300. For example, theanchor cannula 304 may have an inner dimension (e.g., diameter) that is sized to enable at least a portion of themedical device 102 to be received within theanchor cannula 304. In some embodiments, aproximal portion 316 of theanchor deployment device 300 is configured such that themedical device 102 extends through theanchor deployment device 300 and out of the of theanchor deployment device 300 at theproximal portion 316. Such a configuration may enable a user to position theanchor deployment device 300 along and through themedical device 102 in order to secure ananchor element 100 to theanchor deployment device 300 at any desired position. For example, themedical device 102 may be placed within a subject and theanchor deployment device 300 may be slid along themedical device 102. A portion of the anchor deployment device 300 (e.g., the distal portion 312) may be inserted within the subject to secure theanchor element 100 within the subject while themedical device 102 resides within the subject.
Actuation of thehandle 306 may bring theanchor element 100, which is positioned on the anchor cannula 304 (e.g., in a radially enlarged or stretched state), into contact with the deployment cannula 302 (e.g., aleading end 318 of the deployment cannula 302). Thedeployment cannula 302 may act to force (e.g., slide) at least a portion of theanchor element 100 along theanchor cannula 304. For example, thedeployment cannula 302 may force thefirst engagement portion 106 toward thesecond engagement portion 108, thereby deploying thelobes 104 of theanchor element 100. As theanchor cannula 304 is slid within thedeployment cannula 302, theleading end 318 of thedeployment cannula 302 may force theanchor element 100 off of theanchor cannula 304 and onto the medical device 102 (e.g., into the position shown inFIG. 1).
FIG. 6 depicts a cross-sectional view of a portion of theanchor deployment device 300 shown inFIG. 4 with themedical device 102 received in theanchor deployment device 300. As shown inFIG. 6, the inner diameter ID₃₀₄ of theanchor cannula 304 is sized to enable themedical device 102 to be received within theanchor cannula 304. The inner diameter ID₃₀₂ of thedeployment cannula 302 may be greater than an outer dimension OD₃₀₄ of theanchor cannula 304 such that theanchor cannula 304 may be received and movable within thedeployment cannula 302.
FIG. 7 depicts another cross-sectional view of a portion of theanchor deployment device 300 shown inFIG. 4 with themedical device 102 received in theanchor deployment device 300 and theanchor element 100 attached to theanchor deployment device 300. The outer diameter OD₃₀₄ of theanchor cannula 304 may be greater than an inner diameter of theanchor element 100 such that theanchor cannula 304 acts to enlarge a cross-sectional area of the lumen formed within a portion of theanchor element 100 to form an enlarged inner diameter ID₁₀₀ of theanchor element 100 that is substantially equal to the outer diameter OD₃₀₄ of theanchor cannula 304. The enlarged inner diameter ID₁₀₀ of theanchor element 100 may be greater than an outer diameter OD₁₀₂ of themedical device 102 such that the enlarged inner diameter ID₁₀₀ of theanchor element 100 may be deployed over the outer diameter OD₁₀₂ of themedical device 102. When theanchor element 100 is removed from the anchor cannula 304 (e.g., by thedeployment cannula 302 as discussed above), theanchor element 100 may contract toward the initial diameter to the anchor element 100 (e.g., where the initial diameter of theanchor element 100 is less than the outer diameter OD₁₀₂ of the medical device 102) in order to secure theanchor element 100 to themedical device 102.
FIGS. 8A and 8B depict ananchor element 400 in an initial state and a deployed state, respectively. Theanchor element 400 may be similar to and include one or more of the same features and functioning as theanchor elements 100, 200 discussed above with reference toFIGS. 1 through 3B. As shown inFIG. 8A, theanchor element 400 includes alobe portion 405 positioned between theengagement portions 406, 408 of theanchor element 400. The body of theanchor element 400 may form alumen 401 therein. Lobes 404 (e.g., two lobes) of thelobe portion 405 are formed about the anchor element 400 (e.g., at equal circumferential spacing) byslits 412 in the tubular body of theanchor element 400. In the initial state, thelobe portion 405 of theanchor element 400 is substantially parallel to (e.g., coextensive with) a longitudinal axis L₄₀₀ of theanchor element 400.
Referring also toFIG. 8B, theengagement portions 406, 408 may be moved toward each other to transition theanchor element 400 to the deployed state. Theslits 412 enable thelobes 404 to extend outwardly (e.g., in a direction lateral or transverse (e.g., perpendicular) to the longitudinal axis L₄₀₀ of the anchor element 400) from a portion of the anchor element 400 (e.g., from theengagement portions 406, 408).
As depicted, theanchor element 400 may include a biasing feature (e.g., a radial biasing feature). For example, theanchor element 400 may include one ormore springs 414 extending about at least a portion of the anchor element 400 (e.g., theengagement portions 406, 408). In some embodiments, thesprings 414 are disposed on an exterior portion of theanchor element 400. In other embodiments, thesprings 414 may be disposed within theanchor element 400. Thesprings 414 may act to bias theanchor element 400 in (e.g., toward) an initial state. For example, thesprings 414 may act to radially bias theengagement portions 406, 408 of theanchor element 400 inward in a direction toward the lumen 401 (e.g., constricting the lumen 401) such that thesprings 414 bias theengagement portions 406, 408 to or toward an initial state (e.g., an unstretched inner diameter of the anchor element 400). In some embodiments, thesprings 414 act to relatively more rapidly tighten theanchor element 400 around a medical device 102 (see,e.g.,FIG. 5).
It is noted that any anchor element disclosed herein (e.g.,anchor elements 100, 200) may include a radial biasing feature (e.g., springs). In other embodiments, the anchor element may include an axial biasing feature.
FIGS. 9 and 10 depict a perspective view and a side view, respectively, of ananchor deployment device 500. Theanchor deployment device 500 may be similar to and include one or more of the same features and functioning as theanchor deployment device 300 discussed above with reference toFIGS. 4 through 7. As shown inFIGS. 9 and 10, theanchor deployment device 500 includes a first cannula (e.g., deployment cannula 502) and a second cannula (e.g., anchor cannula 504) received at least partially within thedeployment cannula 502. Theanchor deployment device 500 may include a handle 506 (e.g., formed as a hub) coupled to theanchor cannula 504 such that thehandle 506 and theanchor cannula 504 may be moved relative to another portion of the anchor deployment device 500 (e.g., abody 501 of the anchor deployment device 500). For example, thebody 501 of theanchor deployment device 500 may define an opening orchamber 507 in which thehandle 506 is at least partially disposed. In some embodiments, thebody 501 of theanchor deployment device 500 defines atrack 509 in thechamber 507 upon which a portion of the handle 506 (e.g., a complementary portion) may move along (e.g., slide) to guide (e.g., and retain) thehandle 506 and theanchor cannula 504 relative to thebody 501 and thedeployment cannula 502. Movement of thehandle 506 relative to thebody 501 enables a user (e.g., medical practitioner) to slide theanchor cannula 504 relative to thedeployment cannula 502 along a common axis.
As depicted, theanchor deployment device 500 is shown with an anchor element (e.g.,anchor element 400 in a distended state of the inner diameter) positioned on theanchor cannula 504 of theanchor deployment device 500. As above, theanchor deployment device 500 may have an inner dimension (e.g., diameter) that is sized to enable at least a portion of a medical device 102 (FIG. 5) to be received within theanchor cannula 504. As also described above, thehandle 506, theanchor cannula 504, and thedeployment cannula 502 may be utilized to deploy one or more anchor elements on a medical device (e.g.,anchor elements 100, 200, 400 onmedical device 102 as shown and described above).
As further depicted inFIGS. 9 and 10, theanchor deployment device 500 may includeupper handle 510. A first end ofupper handle 510 may include alocking mechanism 512 that holds (e.g., locks, clamps,etc.) the medical device 102 (FIG. 5). For example, thelocking mechanism 512 may secure themedical device 102 when an anchor element is being deployed on the medical device 102 (e.g., when at least a portion of themedical device 102 is resident in a subject).
A second end ofupper handle 510 may include a protrusion orelongated member 514 that engages with thehandle 506 to secure thehandle 506 and theanchor cannula 504. For example, theelongated member 514 of theupper handle 510 may retain thehandle 506 and theanchor cannula 504 and prevent thehandle 506 and theanchor cannula 504 from sliding relative to thebody 501 ofanchor deployment device 500.
Theupper handle 510 may be configured such that the first end and the second end move (e.g., pivot) relative to each other. For example, when thelocking mechanism 512 is securing the medical device 102 (FIG. 5), theelongated member 514 is disengaged with thehandle 506, thereby enabling thehandle 506 and theanchor cannula 504 to move relative to thebody 501. Similarly, when theelongated member 514 is engaged with thehandle 506 and restricting thehandle 506 and theanchor cannula 504 from moving relative to thebody 501, thelocking mechanism 512 is disengaged from themedical device 102, thereby enabling theanchor deployment device 500 to move (e.g., slide) along themedical device 102. Such a configuration may enable theanchor deployment device 500 to be secured to themedical device 102 while an anchor element is being deployed and, likewise, secure theanchor deployment device 500 from any unwanted movement of theanchor cannula 504 relative to thedeployment cannula 502 when theanchor deployment device 500 is being moved and positioned along themedical device 102.
Theanchor deployment device 500 may includerear handle 516 that enables a user to move and position theanchor deployment device 500 along themedical device 102.
It is noted that to the extent that the anchor deployment devices are described in use with a particular anchor element, in other embodiments, the anchor deployment devices may be utilized with any suitable anchor element (e.g.,anchor elements 100, 200, 400).
It is further noted that while the anchor elements and components of the anchor deployment device are primarily discussed herein as having a diameter, these elements are not necessarily limited to circular cross sections. For example, the anchor elements and components of the anchor deployment device, and the lumens formed therein, may have a square, circular, oval, rectangular, or any other suitable cross-sectional shape.
Referring toFIGS. 1 through 10, in operation, a lumen of an anchor element (e.g.,lumen 101, 201, 401 ofanchor element 100, 200, 400) is enlarged to position theanchor element 100, 200, 400 on theanchor cannula 304 of theanchor deployment device 300. A medical device 102 (e.g., a medical device that has already been inserted and positioned within a subject) is positioned within theanchor element 302 and theanchor deployment device 300 andanchor element 100, 200, 400 are moved along themedical device 102 to position theanchor element 100, 200, 400 within the subject. Theanchor element 100, 200, 400 may then be deployed within the subject utilizing thehandle 306 of theanchor deployment device 300 to deploy thelobes 104, 204, 404 of theanchor element 100, 200, 400 and to force theanchor element 100, 200, 400 onto (e.g., about, around) themedical device 102 with thedeployment cannula 302. Constriction of theanchor element 100, 200, 400 about themedical device 102 as theanchor element 100, 200, 400 contracts toward the initial lumen size of theanchor element 100, 200, 400 acts to secure theanchor element 100, 200, 400 about themedical device 102 while both theanchor element 100, 200, 400 and themedical device 102 are positioned within the subject. For example, theanchor element 100, 200, 400 may contract to the initial size of thelumen 101, 201, 401 of theanchor element 100, 200, 400 or to a cross-sectional area between the initial size and the enlarged (e.g., deformed) size of thelumen 101, 201, 401 of theanchor element 100, 200, 400. In some embodiments, the constriction of theanchor element 100, 200, 400 may also constrict or compress a portion of the medical device 102 (e.g., a cannula).
Once theanchor element 100, 200, 400 is placed over themedical device 102 within the subject, thelobes 104, 204, 404 of theanchor element 100, 200, 400 may anchor themedical device 102 by engaging with one or more portions of the subject's tissue to at least partially retain themedical device 102 in a desired position within the subject.
Once being apprised of the instant disclosure, one of ordinary skill in the art will be able to make and use the devices and assemblies disclosed herein. For example, the anchor elements may be formed from a polymer (e.g., a polyurethane such as CARBOTHANE®) and springs may be formed from a metal material (e.g., 316 stainless steel).
The scope of the invention is defined by the appended claims.

Claims

An anchor element assembly comprising:
at least one anchor element having a longitudinal axis, the at least one anchor element comprising:
two engagement portions for securing to at least a portion of a medical device;
at least one lobe section positioned between the two engagement portions and comprising at least one lobe configured to extend transversely from the longitudinal axis of the at least one anchor element when the at least one anchor element is in a deployed state; and
a lumen formed within the at least one anchor element configured to receive at least a portion of a medical device in the lumen; and
an anchor deployment device comprising:
a first cannula configured to receive the at least one anchor element thereon; and
a second cannula having at least a portion of the first cannula received therein,
wherein the first cannula is movable relative to the second cannula, and
wherein the second cannula and the at least one anchor element are mutually configured to:
force the two engagement portions toward each other in order to extend the at least one lobe section to position the at least one anchor element in the deployed state while the at least one anchor element is positioned on the first cannula; and
force the at least one anchor element off of the first cannula in the deployed state in order to secure the at least one anchor element to the at least a portion of the medical device in the deployed state;
wherein an outer dimension of the first cannula of the anchor deployment device is greater than an inner dimension of the at least one anchor element, the first cannula configured to at least partially enlarge the lumen of the at least one anchor element in order to deploy the at least one anchor element over the at least a portion of the medical device;
wherein an inner dimension of the first cannula of the anchor deployment device is greater than an outer dimension of the at least a portion of the medical device, the first cannula configured to receive at least a portion of the medical device within a lumen formed within the first cannula; and
wherein the lumen of the at least one anchor element is configured to contract around the at least a portion of the medical device in order to secure the at least one anchor element to the at least a portion of the medical device.
The anchor element assembly of claim 1, wherein the first cannula is coupled to a hub movably received within a portion of the anchor deployment device such that movement of the hub translates the first cannula relative to the second cannula.
The anchor element assembly of claim 2, wherein the anchor deployment device further comprises a securing member configured to secure the hub to the anchor deployment device to prevent movement of the hub and the first cannula relative to the second cannula.
The anchor element assembly of claim 1 or 3, wherein the anchor deployment device further comprises a locking mechanism configured to secure the medical device to the anchor deployment device.
The anchor element assembly of claim 4, wherein the anchor deployment device further comprises a pivoting handle having the locking mechanism on a first side of the pivoting handle and the securing member on a second side of the pivoting handle, wherein, in a first position of the pivoting handle, the locking mechanism is configured to be engaged with the medical device and disengaged from the hub and, in a second position of the pivoting handle, the locking mechanism is configured to be disengaged from the medical device and engaged with the hub.
The anchor element assembly of any one of claims 1 through 4, wherein the anchor deployment device is configured to at least partially move the at least one anchor element from an initial state where the at least one lobe section of the at least one anchor element is substantially parallel to the longitudinal axis of the at least one anchor element to the deployed state where the at least one lobe of the at least one lobe section extends transversely from the longitudinal axis of the at least one anchor element.
The anchor element assembly of any one of claims 1 through 4, wherein the at least one lobe section of the at least one anchor element comprises at least two lobe sections spaced along the longitudinal axis of the at least one anchor element, each lobe section of the at least two lobe sections comprising at least two lobes.
The anchor element assembly of claim 7, wherein the at least two lobes of a first lobe section of the at least two lobe sections are offset about the longitudinal axis of the at least one anchor element from the at least two lobes of a second lobe section of the at least two lobe sections.